Search Results for Teva

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FDA Approves First Generic Version of Gilead's HIV Drug Truvada By Michael Mezher - Published 09 June 2017

The US Food and Drug Administration (FDA) on Friday announced it has approved Teva Pharmaceuticals' generic version of Gilead's HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate).

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: Truvada, Teva, Gilead, PrEP

Copaxone Generics: Who Will Win First Filer Exclusivity? By Zachary Brennan - Published 25 May 2017

Generic versions of Teva’s multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) are coming, but a closer look at which competitor might win the coveted 180-day exclusivity for its generic reveals an unusual and complex situation.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Copaxone, Teva, Mylan, Momenta, Synthon, Dr. Reddy's

FDA Warns Teva API Plant in China By Zachary Brennan - Published 25 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China.

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Teva, warning letter, FDA inspections

Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: GlaxoSmithKline, Regeneron, Novartis, Teva, BIO, Celgene, AstraZeneca, clinical trial endpoints

FDA Warns Pfizer’s Kansas Site Following Cardboard Found in Sterile Injectables By Zachary Brennan - Published 28 February 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to Pfizer subsidiary Hospira’s Kansas-based site, finding that the company’s investigations into complaints of visible particulates in sterile injectables were inadequate.

Categories: News, US, FDA, Crisis management, Drugs, Manufacturing

Tags: Pfizer, Hospira, Copaxone, Teva, warning letter

Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals By Zachary Brennan - Published 05 January 2017

The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program.

Categories: News, US, Crisis management, Drugs, Government affairs

Tags: 340B, CMS, drug pricing, Medicaid, PhRMA, BIO, Bayer, Teva

FDA Warning Letter Reveals Data and Sterility Issues at Teva Plant in Hungary By Zachary Brennan - Published 25 October 2016

The US Food and Drug Administration (FDA) on Tuesday released the warning letter it sent to Israel-based Teva Pharmaceuticals earlier this month, noting instances of data deletion and manipulation at the company’s manufacturing site in Gödöllő, Hungary.

Categories: News, Europe, US, FDA, Crisis management, Drugs, Manufacturing

Tags: Teva, data manipulation, aseptic processing, sterility failure

FDA Warns Teva’s Banned Hungary Manufacturing Facility By Zachary Brennan - Published 19 October 2016

The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program.

Categories: News, Europe, FDA, Compliance, Crisis management, Drugs, Government affairs, Manufacturing

Tags: warning letters, Teva, data integrity

MHRA Lifts Suspension on Teva Thyroid Drug By Michael Mezher - Published 19 October 2016

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced it has lifted its suspension of Israeli drugmaker Teva Pharmaceuticals' levothyroxine tablets used to treat hypothyroidism.

Categories: News, Europe, MHRA, Generic drugs, Manufacturing, Submission and registration

Tags: levothyroxine, Teva

Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic By Zachary Brennan - Published 28 September 2016

Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Medical Devices, Regulatory strategy

Tags: Mylan, Teva, EpiPen, Patty Murray, citizen petition, pay-for-delay settlement

Teva’s Cephalon Reaches $125m Settlement With 48 States Due to Generic Delays By Zachary Brennan - Published 04 August 2016

Teva Pharmaceutical’s Cephalon and state attorneys general on Thursday announced a $125 million, 48-state settlement after an investigation into the company’s delaying of generic versions of its moneymaker.

Categories: News, US, FTC, Business and Leadership, Generic drugs, Regulatory intelligence

Tags: Provigil, Cephalon, Teva, pay for delay

Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition By Zachary Brennan - Published 27 July 2016

The Federal Trade Commission (FTC) on Wednesday announced that generic drugmaker Teva Pharmaceuticals has agreed to sell its rights and assets to 79 pharmaceuticals to settle FTC charges that its proposed $40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anticompetitive.

Categories: News, US, FTC, Crisis management, Generic drugs, Manufacturing, Project management

Tags: Teva, Allergan, generic drugs, generic drug competition

FDA Evaluating Risk of Burns and Scars With Migraine Patch By Zachary Brennan - Published 02 June 2016

Almost five years since the US Food and Drug Administration (FDA) rejected the approval of the Zecuity migraine patch because of burns (and then later approved a revamped version), the agency said Thursday it’s now investigating the battery-powered patch as “a large number of patients have reported they experienced burns or scars on the skin where the patch was worn.”

Categories: News, US, FDA, Combination products, Crisis management, Postmarket surveillance

Tags: Zecuity, migraine patch, drug patch burns, Teva Pharmaceuticals, NuPathe

FDA Bans Imports From Teva’s Hungary Plant Except Two Drugs in Shortage By Zachary Brennan - Published 02 June 2016

The US Food and Drug Administration (FDA) late last week announced an import alert prohibiting drugs made at the  Gödöllő, Hungary-based manufacturing site from entering the US.

Categories: News, Europe, US, FDA, Crisis management, Drugs, Manufacturing

Tags: Hungarian drug manufacturing, Teva Pharmaceuticals, generic injectable medicines

EU High Court Upholds Orphan Exclusivity Ruling By Michael Mezher - Published 23 March 2016

Earlier this month, the EU's top court upheld a major ruling with implications for orphan drug exclusivity by rejecting an appeal by generic drugmaker Teva Pharmaceuticals Europe.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Orphan products, Submission and registration

Tags: Glivec, Gleevec, Tasigna, Teva, Novartis, Market exclusivity

EU Court Rules on Orphan Product Exclusivity By Michael Mezher - Published 19 March 2015

A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity.

Categories: News, Europe, EC, EMA, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: General Court of the Court of Justice of the European Union, CJEU, Orphan Product Designation, Market Exclusivity, Glivec, Tasigna, Teva

Untitled Letter to Teva Cites Unsubstantiated Claims and Unfair Aesthetics By Alexander Gaffney, RF News Editor - Published 22 April 2013

Categories: US, FDA

Tags: OPDP, Untitled Letter, Teva, pharmaceutical, drug

Facing Criticism, FDA Rethinking Some Therapeutic Equivalence Standards By Alexander Gaffney, RF News Editor - Published 01 November 2012

Categories: FDA

Tags: Therapeutic Equivalence, Externded Release, Impax, Budeprion, Wellbutrin, Geba, BE, Teva, Latest News, bioequivalence

FDA Approves Teva's CML Drug Published 26 October 2012

Categories: FDA

Tags: Synribo, Pfizer, Leukemia, CML, Teva, Latest News

FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos Published 23 October 2012

Categories: FDA

Tags: Takeda, Actos, Approve, Diabetes, 180-Day Exclusivity, Mylan, ANDA, Watson, Teva, Latest News

Consumers Warned of Fake Adderall in US By Alexander Gaffney - Published 30 May 2012

Categories: FDA

Tags: Online Pharmacy, Adderall, Counterfeit, Shortages, Teva, amphetamine salts, ADHD, DEA, Latest News

FDA Approves Generic Lexapro By Alexander Gaffney - Published 14 March 2012

Categories: FDA

Tags: Lexapro, Antidepressant, Forest, Exclusivity, Generic, ANDA, Teva, Latest News, 180-Day

Pendergast, Pitts: Sebelius' Decision on Plan B Political, Step Down a 'Slippery Slope' By Alexander Gaffney - Published 03 January 2012

Categories: FDA

Tags: Teva, Plan B, Mary Pendergast, Peter Pitts, Sebelius, HHS, Latest News, DHHS